What was the FDA thinking?

If the FDA (www.fda.gov) wanted to make bigger headlines this week – or draw more more laughs -- it could have hardly chosen a better target: Cheerios.

Yes, the agency Congress established to protect us from adulterated foods and unsafe drugs decided to take on America’s most popular breakfast cereal – or at least General Mills’ claims that eating Cheerios can help lower cholesterol and prevent heart disease. In particular, the agency sent a letter to the chairman of General Mills alleging “serious violations of the Federal Food, Drug, and Cosmetic Act.”

There’s a lot of legalese in this communication, but here’s the short version: the government says General Mills can’t make this claim unless it wants to register Cheerios as a drug. Moreover, if it doesn’t modify its claims, the company risks having Uncle Sam seize all those offending boxes of Cheerios and remove them from the store shelves.

Now I admit to a certain conflict of interest here. As I write this, I am dipping into the very box of Cheerios (Honey Nut variety) that I snatched from the pantry to investigate the FDA’s assertion when the story first crossed my desk. As breakfast cereals go, this one is tasty and certainly not as bad for you as say, Froot Loops, or Count Chocula.

I also feel obligated to inform you that I am consuming this drug without a prescription. So, yes, I think the FDA looks a bit foolish here. But intentionally or not, it has focused the public’s attention on cholesterol and the notion of heart-healthy diets. If you’re a doctor and your patients are asking you about this brouhaha, it’s probably a good thing.

Here’s what the dispute is actually about: fiber, more precisely, soluble fiber.

Back in 1997, at the request of Quaker Oats, the FDA issued a ruling that cereal makers could include claims that certain oat products containing at least 0.75 grams of soluble fiber per serving could help lower cholesterol as part of a heart-healthy, low-fat, high-fiber diet.

The “soluble” is important here, because most fruits, nuts, vegetables, and grains have a lot more insoluble fiber -- the kind that passes through and keeps the digestive system clean (which is also good but doesn’t have any effect on cholesterol.

The FDA says it takes at least 3 grams of soluble fiber daily to affect cholesterol levels. Since the label on my box of Honey Nut Cheerios says it has less than one gram, I can assume it would take at least three servings a day to make a dent in my cholesterol level. Or, I can eat a bowl of Cheerios and get the rest from some other source of soluble fiber, such as apples, bananas, peaches, legumes, peas, beans, broccoli, or carrots.

In announcing the 1997 rule, the FDA was very specific about how cholesterol claims may be phrased -- and emphasized that a claim must be part of a broader statement about low-fat diets. In a talking paper to the staff, officials wrote the following:

“The words, ‘Diets low in saturated fat and cholesterol’ must be included in any such health claim because FDA concluded, after reviewing comments, that consumers might otherwise be misled into thinking that eating a diet high in oats is all that is necessary to reduce the risk of heart disease.”

So now the FDA and General Mills will get to duke it out over the wording on Cheerios packages. This will be a doozy because Cheerios comes in a variety of boxes, each of which has a slightly different wording. I can picture entire teams of lawyers arguing for months to determine whether to use the word “may” or “might.” Your tax dollars at work.

Which brings us back to the question, “Why would the FDA do this?”

When news about the General Mills letter broke, the right-wing blogosphere took after the FDA like a pack of pit bulls on amphetamines -- screaming about yet another example of Obama Administration radical one-world socialism (or whatever). But the administration doesn’t worry much about them: their guys lost the last election -- big time.

On the other hand, the left can’t be happy, either. For an agency that progressives have long attacked for failing to protect the public from dangerous drugs and tainted imports, this seems pretty frivolous. And it opens the administration to attacks from the right.

Was it political? General Mills is certainly a player in the political contribution arena, but not a big one. According to Federal Election Commission records, the General Mills Political Action Committee gave $230,000 to federal candidates during the 2008 election cycle. Of that, 62 percent went to Republicans. This is hardly unusual in American politics.

The PAC did give $2,000 to Hillary Clinton during her bitter but unsuccessful battle with Barack Obama in the presidential primaries, so the company can hardly be viewed as an Obama supporter. But it also gave $1,000 to Rep. Rahm Emanuel (D-Ill.), who became Obama’s chief-of-staff. Call it a draw.

Once we get past the political ranting, who wins and who loses?

In the long run, both sides win. The FDA gets to show it’s not afraid to tackle the big boys. General Mills is a pretty easy target, and it won’t be hard to get a “win.” The government doesn’t want Cheerios off the shelves -- it wants a few wording changes and bragging rights.

Meanwhile, General Mills has just received a hundred million dollars worth of free advertising for Cheerios. Bad publicity? No such thing. Nobody’s claiming the stuff is bad for you. In fact, the dietitians on the network news were gushing about how good these whole grain products are.

My bottom line: Conspiracy. Fiber is one of the world's dullest subjects -- and for few days at least, the world was talking about it.

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